1148 infection control & hospital epidemiology october 2017, vol. 38, no. 10
textiles demonstrate activity against pathogens such as S. aureus, Candida albicans, Acinetobacter spp., vegetative Clostridium difficile, and Klebsiella pneumoniae.8–10 However, data to support the use of antimicrobial-impregnated textiles in clinical practice are limited.11–15 We designed the Antimicrobial Scrub Contamination and
Transmission (ASCOT) Trial (1) to determine whether antimicrobial-impregnated surgical scrubs decrease the burden of HCP clothing contamination compared to standard surgical scrubs following a 12-hour intensive care unit (ICU) shift and (2) to characterize the transmission dynamics of epidemiologically-important pathogens among the patient, the environment, and the HCP, a group we labeled the “transmission triangle.”
methods Study Design and Participants
We performed this blinded, 3-arm, randomized controlled trial with crossover design in 2 ICUs at Duke University Hospital between June 15, 2015, and January 10, 2016. The study included 1 control arm and 2 intervention arms. Nurses wore standard cotton-polyester surgical scrubs in the control arm. In the Scrub 1 intervention arm, nurses wore surgical scrubs that contained a
complex element compound with a silver alloy embedded in its fibers. In the Scrub 2 intervention arm, nurses wore surgical scrubs impregnated with an organosilane-based quaternary ammonium and a hydrophobic fluoroacrylate copolymer emulsion. Nurses participated in each arm during 3 consecutive 12-hour shifts in the ICU. Study personnel laundered all study scrubs 5 times and delivered them to nurse participants in plastic bags. Nurses donned the study scrubs at home and presented to work according to their routines. In this study, we enrolled nurses from the medical ICU and
surgical ICU at Duke University Hospital, a 936-bed tertiary-care hospital in Durham, North Carolina, where ICU nurses typically care for patients in 2 ICU rooms each shift. All nurses working in themedical ICU or the surgical ICU were eligible for enrollment. Data from enrolled nurses who failed to complete all 3 shifts were excluded. Patients known to be colonized or infected with any multidrug-resistant pathogen were routinely placed on contact precautions, during which all HCPs wore gowns and gloves upon entry into the room. These ICUs did not perform routine active surveillance during the study period. The Duke University Health System Institutional Review
Board approved the study. Nurses provided written informed consent. We received a waiver of informed consent to collect data and specimens from the patients receiving care from enrolled nurses. The study is registered on
ClinicalTrials.gov (NCT 02645214).
Randomization and Blinding
After obtaining consent from the nurse subject, the study coordinator provided the nurse with 3 sets of
scrubs.Nurses were
blinded to the type of scrub. Brands and labelswere removed from scrubs; all scrubs were “Duke blue” in color. The study coordinator provided written and verbal instructions on which scrubs to wear with each shift. Nurse participants were randomized to 1 of 6 sequences of scrubs (Supplementary Table 1). The nurses wore a different scrub type during each of the 3 12-hour shifts, so each nurse participated in each study arm in a 1:1:1 ratio. The study team was not blinded during specimen and data collection. However, microbiology personnel were blinded to study arm allocation during the analysis of specimens.
Procedures
The study coordinator arrived at the ICU prior to the beginning of each shift to obtain cultures from each nurse’s scrubs (sleeve, abdomen, and pocket) as well as specified “high touch” surfaces (bedrail, bed, and supply cart) in each of that nurse’s2assigned rooms (Supplementary Figure 1). The coordinator repeated the process of obtaining samples from each nurse’sscrubs andassigned roomsatthe endofthe nurse’s shift. The study coordinator also obtained cultures from each patient who received care from a participating nurse during that shift. Specimens were collected from the anterior nares, the perirectal area, and from the integument (i.e., wounds, drains, or axilla). Microbiological methods are provided in detail in the Supplementary Material. Cultures from each nurse/patient/room grouping were analyzed for the presence of similar species. A potential transmission event or “acquisition” was defined as the new identification of a target pathogen on nurse clothing, the patient, or the environment. A confirmed transmission event or “transmission” was defined as an acquisition event for which a source from the transmission triangle could be identified and confirmed. Organisms involved in acquisition events were analyzed for transmission events using pulsed-field gel electrophoresis (PFGE; see Supplementary Material).16 Finally, each nurse completed a 4-question survey at the
end of the shift to describe how the scrubs worn during the shift compared to their standard work scrubs. Ultimately, each nurse answered 3 surveys, corresponding with each arm in the study.
Outcomes
The primary outcome of our study was the change in total contamination on nurse scrubs, measured as the sum of colony-forming units (CFU) of bacteria identified on nurse scrubs from each clothing location. The following predetermined secondary outcomes were measured: (1) the presence or absence of individual target pathogens; (2) the number and proportion of acquisitions and transmission events; and (3) HCP perceptions of clothing.
Statistical Analysis
This prospective, blinded, randomized trial was designed to test the hypothesis that antimicrobial-impregnated scrubs
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